Product Development Biomedical Engineer

David McIntyre

Northville, MI *****, 586-***-**** *****.************@*****.*** LinkedIn

Business-Driven Biomedical Engineer

Experienced biomedical engineer in execution of testing, integration, validation, and production to positively impact profitability. Leverages cross-functional expertise to connect big picture business needs to engineering specifics and problem solves at engineering level. Excellent communication skills, ensuring product team needs are met within time sensitive deadlines.

Proficient in and working experience with: Microsoft MS Office (Word, Excel, Sensei IQ, etc.) Minitab 17 MATLAB DOORS

System Integration

New Product Development

Project Planning

Interpersonal Communication Skills

Verification / Validation

Failure Mode Analysis

Analytics/Tracking & Reporting Metrics

Regulatory Compliance

Professional Experience

TERUMO CARDIOVASCULAR, Ann Arbor, MI 2015 - 2024

Engineering Supervisor, Product Development 2022 - 2024

Led system accuracy design verification activities, which recently received 510k clearance, for real-time continuous monitoring system (CDI OneView) used during cardiopulmonary bypass surgery

Successfully orchestrated rigorous cleaning / reprocessing testing, which evaluated material selection and surface geometry of the CDI OneView in response to FDA questions upon original submittal of 510k

Directed new product development activities aimed at the implementation of new parameters and algorithms for CDI OneView

Drafted technical instructions and performance specifications to CDI OneView’s instructions for use (IFU)

Facilitated an international effort whereby CDI OneView graphical user interface could recognize internation inputs

Headed multi-year external calibration reduction effort of product development equipment, which yielded a 47.6% cost reduction

Led sustaining engineering and production process improvement activities seeking to improve product yield by 15.3%

Interfaced with Supply Quality Engineering to ensure that supplier obsolescence plans would not negatively impact operations – identified source alternative for adhesive products that retain material properties required for the CDI OneView shunt sensor chemistries

Prepared budgets, identified / implemented cost reduction efforts related to supplies, equipment, and maintenance services

Supervised team of 15+ direct reports; responsible for managing / leading team to meet project and departmental goals

Mentoring associates to improve professional development and overall work performance

Supervisor, Design Assessment Lab, Product Development 2019 - 2022

Projects supervised include mechanical perfusion products, continuous monitoring systems of key blood parameters, as well as key disposable supplies, which are all used during life-saving cardiac and thoracic surgery

Developed testing strategy that reduced test duration by 2 months and reduced cost by 38.9% – yielding a $390K savings

Directed testing in expanded operating ranges and improved accuracy, while also achieving more consistent and repeatable results

Completed Leadership Academy—a company-hosted leadership development program for those identified as high performers

Led successful verification activities while serving as a representative user group for validation activities in 510k submission to FDA

Recruited vendor, identified user needs, and directed non-product software development activities resulting in more effective testing

Managed calibration/preventative maintenance schedules of select equipment, including nonconformance prevention/resolution

Conducted goal setting activities and implementing development plans for direct reports

Engineer II, Design Assessment Group 2017 - 2019

Lead engineer for system accuracy design verification testing of the CDI System 550, which received 510k clearance

Coordinated all aspects of aforementioned testing, which occurred during day and night shifts as well as 7 days a week

Activities involved investigating expansion of system operating ranges, accuracy evaluation, evaluation of alternative chemistries and molecular compositions for sensors, root-cause analysis of molecular cages, and replication of user failure mode practices

Sole protocol author over this time; incorporated usability and human factor elements to improve execution and reduce deviations

Created new test methods and improved existing test methods as a part of process improvement

Led two laboratory moves ensuring appropriate equipment assessments and qualifications were performed prior to resumed use

Engineer I, Design Assessment Group 2015 - 2017

Promoted to Engineer I from Associate Test Engineer (2014), responsible for verification and validation testing

Started while company was under FDA consent decree; since then, have effectively worked with a world class quality system

Worked on projects that required understanding of common standards such as ASTM, ISO, ISTA, among others

Led chemical compatibility evaluations of material properties for two product lines; this continues to be the internal benchmark testing

Involvement in validation testing for recall, which was reviewed and accepted during follow up audit by FDA

Education

Wayne State University, Detroit, MI Master of Science, December 2021

GPA: 3.8/4.0; Dean’s List Biomedical Engineering

Kalamazoo College, Kalamazoo, MI Bachelor of Science, June 2014 Chemistry

Achievements

Track record of success – highlighted by the five positions of increasing responsibility and impact over my 10-year career in the highly regulated medical device industry

510k clearance for multiple medical devices – once as the lead engineer (CDI 550) and once as the lead supervisor (CDI OneView) of system accuracy design verification activities

New product development – directed the development and implementation of new parameters and algorithms for CDI monitoring systems

Cost reduction and efficiencies – multiple efforts that successfully reduced expenses and improved throughput

Team leadership and communication – completed Leadership Academy; supervised teams of 15+ members, managing and leading them to meet project and departmental goals; mentored associates to enhance their professional development and overall work performance

Contact this candidate